Aneurysmal Subarachnoid HemorrhageHMANCT07761520
Prevention of Ischemia in Aneurysmal Subarachnoid Hemorrhage Through Remote Ischemic Preconditioning
A study testing Remote Ischemic Preconditioning in people with Aneurysmal Subarachnoid Hemorrhage, run by Centre Hospitalier Universitaire de Nice.
Trial summary
Aneurysmal subarachnoid hemorrhage (SAH) is a severe form of stroke caused by bleeding around the brain. Despite early treatment of the initial hemorrhage, many patients develop delayed cerebral ischemia several days later, which is a major cause of neurological disability, cognitive impairment, and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Remote Ischemic Preconditioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18 years
- Hospitalization for aneurysmal subarachnoid hemorrhage confirmed by CT scan and/or lumbar puncture
- Confirmation of intracranial aneurysm by CT angiography and/or cerebral angiography
- Written informed consent obtained from the patient or legal representative
- Affiliation to a social security system
Who cannot join
- Skin, orthopedic, or vascular conditions of the limbs contraindicating ischemic preconditioning (e.g., ulcers, fractures, deep vein thrombosis)
- Pregnancy
- Withdrawal of informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Remote Ischemic Preconditioning (RIPC) and Aneurysmal Subarachnoid Hemorrhage (SAH)
Aneurysmal subarachnoid hemorrhage (SAH) is a severe form of stroke caused by bleeding around the brain. Despite early treatment of the initial hemorrhage, many patients develop delayed cerebral ischemia several days later, which is a major cause of neurological disability, cognitive impairment, and mortality. Current preventive and therapeutic strategies are only partially effective, highlighting the need for new treatment approaches.
This study investigates a simple, non-invasive technique called remote ischemic preconditioning (RIPC). RIPC consists of brief, repeated cycles of limb ischemia and reperfusion induced by a blood pressure cuff. RIPC is thought to activate endogenous protective mechanisms that may improve the brain's tolerance to ischemia. Although beneficial effects have been reported in experimental models and cardiovascular diseases, its clinical efficacy in aneurysmal SAH remains uncertain.
Read more
In this randomized, controlled, single-blinded, multicenter study, adult patients admitted with aneyrysmal SAH will be randomly assigned to receive RIPC or a sham procedure. The RIPC group will undergo cycles of brief lower-limb ischemia using a pressure cuff, while the sham group will receive an identical procedure without inducing ischemia. Patients and neurologists assessing outcomes will remain blinded to group allocation.
The intervention will be performed every two days from day 2 to day 10 after hemorrhage. Neurological outcome will be assessed at 3 months using the modified Rankin Scale. Secondary outcomes include mortality at 3 months, long-term neurological and cognitive function outcomes at 12 months, and the incidence of adverse events related to the procedure.
If effective, RIPC could become a simple, low-cost, widely accessible method to reduce disability after SAH. The results may help improve future treatment strategies for this severe condition.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- Remote Ischemic Preconditioning, Sham Ischemic Preconditioning
- Keywords
- Aneurysmal Subarachnoid Hemorrhage (aSAH), Remote Ischemic Preconditioning (RIPC)
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Ischemic PreconditioningProcedure or surgery
Three cycles of lower-limb ischemia and reperfusion using a blood pressure cuff inflated to 20 mmHg above systolic blood pressure for 5 minutes followed by 5 minutes of reperfusion. The procedure is performed every two days from day 2 to day 10 after aneurysmal subarachnoid hemorrhage.
Sham Ischemic PreconditioningProcedure or surgery
Identical procedure to the experimental arm, except the cuff is inflated to only 30 mmHg, insufficient to induce ischemia, giving the sensation of pressure without therapeutic effect. Performed every two days from day 2 to day 10 post-hemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Preconditioning (RIPC) | Experimental | Not described Receives: Procedure: Remote Ischemic Preconditioning |
| Sham Procedure | Placebo comparator | Not described Receives: Procedure: Sham Ischemic Preconditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurological Functional Outcome at 3 Months (mRS)
Assessment of neurological disability and dependency using the modified Rankin Scale (mRS) performed by a blinded neurologist. The mRS is a 6-point scale (0 to 5), with 5 being a severe disability.
Measured: 3 months (+/- 15 days) post-aneurysmal subarachnoid hemorrhage
Secondary outcomes (5)
Evaluation of mortality at 3 Months
Comparison of all-cause mortality between the RIPC group and the sham group
Measured: From day 0 to 3 months post-hemorrhage
Long-term Neurological Outcome at 12 Months (mRS)
Assessment of long-term neurological disability and dependency using the modified Rankin Scale (mRS) performed by a blinded neurologist. The mRS is a 6-point scale (0 to 5), with 5 being a severe disability.
Measured: 12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
Evaluation of Cognitive Function at 12 months (MMSE)
Evaluation of cognitive performance assessed using the Mini-Mental State Examination (MMSE). The MMSE score ranks from 0 to 30, with 30 being a normal congnitive performance and 0 serious cognitive impairments.
Measured: 12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
Evaluation of Cognitive Function at 12 months (MoCA)
Evaluation of cognitive performance assessed using the Montreal Cognitive Assessment (MoCA). The MoCA is scored out of 30 points, with high scores suggesting mild or no cognitive impairments, and low scores severe cognitive impairments.
Measured: 12 months (+/- 30 days) post-aneurysmal subarachnoid hemorrhage
Safety Outcomes
Incidence, nature, and severity of adverse events and serious adverse events occurring during the study period.
Measured: From day 0 until 12 months post-aneurysmal subarachnoid hemorrhage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761520
- Sponsor's protocol ID
- 24-AOI-04
- Acronym
- HMA
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No